Manufacturing Supervisor - Advanced Therapies

Initial Therapeutics, Inc.; Lebanon (IN); On-site; USD 48,000 - 79,000; Full time

Benefits offered by this job

Company bonus

401(k) plan

Pension

Vacation benefits

Medical, dental, vision benefits

Flexible spending accounts

Life insurance

Leave benefits

Well-being program

Job summary

Lilly is constructing a cutting-edge manufacturing site in Lebanon, Indiana for advanced therapies. The Supervisor will lead Production Operators on shift, guiding startup activities and ensuring production targets are met while maintaining quality and safety standards.

Initially, the role focuses on startup tasks and staffing, with progression to directing daily operations as the plant comes online. Strong leadership and GMP knowledge are essential for success.

Qualifications

• Three years of experience in a regulated industry, preferably GMP environment.
• HS diploma/GED required.
• Authorized to work in the United States on a full-time basis; Lilly will not sponsor work visas.

Responsibilities

• Lead Operators and direct activities to startup the new facility.
• Manage shift during production, ensuring targets are met.
• Oversee quality, EH&S audits, and compliant documentation.
• Bridge with maintenance and support teams to execute tasks on schedule.
• Conduct start-up activities and training; participate in interviewing and onboarding.

Skills

Leadership

People management

Communication

Problem solving

Attention to detail

Organization

Safety awareness

Education

HS diploma/GED

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but its work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

Lilly is currently constructing a cutting-edge facility for the manufacture of new modalities including Gene Therapy in Lebanon, Indiana. This facility will be Lilly's most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety, quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to start up the facility for both clinical and commercial supply.

This is an exciting opportunity to help start up a state-of-the-art facility and build a manufacturing supply chain from ground-up.

The Supervisor provides leadership and direct supervision to the Production Operators at the Lebanon Advanced Therapies, LP2 site.

Initially, the Supervisor will be responsible for leading Operators and carrying out tasks associated with bringing the new facility on-line. After the plant is running, the Supervisor will be responsible for directing activities on their shift in alignment with production targets and leadership direction. The Supervisor is the management representative on shift.

As a Supervisor, your responsibilities will include:

People Management

• Responsible for individual’s performance, manage employee relations, 1:1 time.
• Be a role model for personnel in terms of performance, behaviors.
• Effectively assign tasks and completion criteria.
• Work with other operations and support resources to assure all activities have adequate operator coverage to ensure production targets or milestones are met.
• Follow and ensure adherence with vacation/absence/overtime policies.
• Conduct thorough information pass downs to ensure the appropriate personnel are aware of all issues and progress made on tasks.
• Lead teams as necessary to accomplish plant start-up and team goals.
• Participate in any start-up activities, including IQ/OQ/PQ/PV/CV, procedure reviews, and training reviews.
• Participate in Operator interviewing, on-boarding and deliver training

Compliance Culture

• Help to promote a culture of quality and safety compliance within the area by demonstrating the desired behaviors.
• Ensure that all operations personnel are adhering to the relevant compliance procedures.
• Organize, participate in, and/or lead routine Quality and EH&S audits/inspections of the facility with operators and support personnel.
• Ensure all required documentation are complete and accurate.
• Maintain housekeeping standards within their assigned areas and the building in general.

Routine Production and Start-up

• Run morning/ shift team meetings.
• Escalate issues and barriers to start up and efficient execution of tasks where appropriate.
• Co-ordinate immediate response to major Quality and HSE events in off - hrs, as necessary.
• Assignment of operators to specific tasks for the day based on the production schedule or start-up milestones outlined at morning meeting.
• Liaise with maintenance and other support teams to execute tasks. Work closely with technical support to ensure activities performed in a compliant manner.
• Ensure production plan or start-up milestones are met.
• Ensure all relevant documentation is completed by end of day/shift.

Minimum Requirements:

• Three years of experience in a regulated industry, preferably GMP environment.
• HS diploma/GED required.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Additional Preferences:

• Requires learning and understanding Good Manufacturing Practices and strict adherence to GMP regulations.
• Will be expected to adhere to all safety and environmental guidelines and to promote safety and environmental compliance in all areas.
• Good organization skills.
• Ability to demonstrate attention to detail.
• Good communications skills (both oral and written).
• Technical problem solving skills.
• Strong Leadership skills.
• Previous manufacturing Supervisor experience.

Other Information:

• During the start-up phase of the project, the shift will be primarily day shift. As the site nears normal operation, shift work will be required. Anticipated to be 10 hours shifts.
• Some overtime may be required.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$35.33 - $57.12

• Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
• eligibility to participate in a company-sponsored 401(k)
• pension
• vacation benefits
• eligibility for medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance and death benefits
• certain time off and leave of absence benefits
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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